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Immuno-oncology refers to drugs that are used to stimulate the human immune system to target the fight against cancer. The immune system is capable of recognizing and eliminating foreign substances, including tumor cells. Tumors have, however, been able to escape detection by the immune system. There are drugs that can empower the immune system cells to attack tumor cells. Natural Killer (NK) cells are the main cells involved in the natural immune response. Once an immune response is initiated, the immune response can be sustained through memory, called adaptive immunity. Cytotoxic T cells are the main cells involved with adaptive immunity. The anti-cancer activity of NK cells and cytotoxic T cells is done through activating and inhibiting signal pathways.

Chimeric antigen receptor (CAR) T-cell therapy will change the way cancer is being treated. In the second half of 2017, the first two drugs in this new class of therapy were approved. Autologous T-cells that have been re-engineered can resist the immunosuppressive effects of tumors. The approved CAR-T therapies are directed against CD19 antigens and are approved to treat B-cell lymphoma and acute lymphocytic leukemia’s, both B-cell mediated diseases. The process involved engineering autologous antigen presenting cells removed from the patient and run through a manufacturing process that takes 17 to 29 days depending on the drug before being infused back into the patient. There are over 200 clinical trials underway with CAR-T therapeutics, some trials in combination with already approved checkpoint inhibitors. The autologous therapies are patient-specific personalized treatments. The costs are staggering for these therapies, with treatments for the drug alone costing hundreds of thousands of dollars. That does not include the costs for other chemotherapies, hospital inpatient, and ICU care costs. Hospitals and clinics running the trials have experienced doctors and nurses that know how to handle this therapy. Expanding to new treatment arenas will be a challenge.

Research advances in combination trials targeting more than one pathway may increase response rates over single targeted agents. If a combination product is produced by one company, it could be priced more competitively than targeted agents developed and marketed through a competitors’ alliance.

New approaches to adoptive T-cell therapies remain a hurdle, but the ultimate goals of increasing overall survival are not insurmountable. Changes in standards-of-care may limit access to patients for clinical trials for these new therapies.

Key Issues Addressed

What adoptive T-cell (CAR-T & TCR) therapies are in development and for what indications?

What products and indications will be launched in the next 7 years?

Who is investing in the development of adoptive T-cell therapies, at what phase, and at what level of deal funding?

What are some of the cost implications for adoptive T-cell therapies, especially when combined with other immuno-oncology therapies?

What are the challenges to development and commercialization of adoptive T-cell therapies?

What challenges do payors face related to the high cost of specialty therapeutics?